Our services include:
• Quality management support
• System development
• Clinical evaluation
• Medical device software specialist services
• Regulated software validation
• Quality and regulatory consulting
• European Authorized Representation
QAdvis breakfast seminar 18th December in Kista
Technical Documentation for medical devices
Learn how to succeed with your Technical Documentation
All medical devices sold in Europe must comply with relevant medical device regulations. The Technical Documentation is your proof of compliance. In this seminar, you will get to know more about how to avoid common mistakes and how to speed up the process of review and CE marking.
The seminar is intended for medtech professionals working within the field of QA/RA and product development. No prior knowledge required.
- Why Technical Documentation?
- MDR Annex II
- MDR Annex III in short
- Common mistakes
- Recommendations of what needs to be checked before submitting to a Notified Body
Maria Eklycke, Quality and Regulatory Consultant at Qadvis.
You can read more about Maria here
Date and time
Date: 11 October 2019
Time: 7.30 – 10.00
Breakfast is served from 07.30 and the seminar begins at 8.00.
The seminar ends around 9.00, with time for questions afterwards.
Sveavägen 63, Stockholm
The seminar is arranged by Swedish Medtech in co-operation with QAdvis. To register go to Swedish Medtch
If you have any questions, please get in contact with Pernilla Andrée:
By phone: +46-(0)8-586 246 17 or send an email firstname.lastname@example.org
The seminar is free of charge and we apply a no-show fee of 500 SEK.
The number of seats is limited, and registration is binding. If you have registered, but are unable to attend, you may let a colleague from your company attend in your place.